The following data is part of a premarket notification filed by Mercia Diagnostics Ltd. with the FDA for Super Duo.
| Device ID | K892802 |
| 510k Number | K892802 |
| Device Name: | SUPER DUO |
| Classification | Kit, Screening, Trichomonas |
| Applicant | MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Contact | David H Lewis |
| Correspondent | David H Lewis MERCIA DIAGNOSTICS LTD. MERCIA HOUSEET BROADFORD PARK Guildford, Surrey England, GB Gu4 8ew |
| Product Code | JWZ |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-17 |
| Decision Date | 1989-06-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SUPER DUO 98570745 not registered Live/Pending |
Mai Phuong Dang 2024-05-28 |
![]() SUPER DUO 87112080 5294057 Live/Registered |
Badmaev Vladimir 2016-07-21 |